A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Type 1 Diabetes

Treatments: Drug: VX-264

Study type: Interventional

Funder types: Industry

Identifiers

NCT05791201

2024-515583-32-00 (EU Trial (CTIS) Number)

VX22-264-101

Details and patient eligibility

About

The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Clinical history of T1D with greater than or equal to (>=) 5 years duration
• Participant is on a stable diabetic treatment
• Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study

Key Exclusion Criteria:

• Prior islet cell transplant, organ transplant, or cell therapy

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

VX-264

Experimental group

Treatment:

Drug: VX-264